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December 19, 2005 Playing
the EHR Donor Game To overcome barriers to adopting technology in individual practices, Health and Human Services (HHS) issued proposed regulations that spell out how to receive a nonmonetary donation. Three words will determine whether you can accept a donation of hardware, software, or training services: “necessary” and “used solely.” The strategic placement of these words in the ePrescribing Safe Harbor and the EHR (Electronic Health Record) Stark Exception proposed regulations reflects short-term incentives to support the urgent adoption of electronic exchange of health information from two agencies within the HHS.1,2 The purpose of this column is not to offer legal advice. If you plan to take advantage of the Stark Exception or ePrescribing Safe Harbors and get in the EHR donor game, consult a health law attorney. Your attorney should guide you through the complexities of Stark or Anti-Kickback Rules. The objective here is to bundle the proposed regulations into understandable concepts so you know where to begin your EHR donor discussions. The HHS, through the Office of the Inspector General (OIG), promulgates a “safe harbor” for some e-prescribing transactions. A safe harbor means that if you fit within the limitations, you’ll be protected from enforcement. If you don’t fit, you won’t be safe. Simultaneously, the Centers for Medicare & Medicaid Services (CMS) supports certain e-prescribing and EHR arrangements. Both proposed regulations not only define how a technology donation can work, but are also intended to improve quality of care and patient safety. The proposed regulations come with significant protections and limit the risk of harm to the federal healthcare programs. “‘Necessary’ and ‘used solely’ reflect the historical reluctance of OIG and CMS to tolerate free or reduced-priced items or services,” said Sean Timmons, JD, associate with Smith Anderson Blount Dorsett Mitchell & Jernigan, one of the guest lecturers at an audio seminar held in mid-November. In the 90-minute presentation, participants were briefed on the proposed ePrescribing Safe Harbor and EHR Stark Exception proposed regulations. Hardware,
Software, Training Donations The definition of “used solely,” Timmons explained, is that the donation must be used solely for one purpose. For example, a hospital can donate hardware, software, and training services necessary and “used solely” to receive and transmit e-prescribing information. However, the software cannot be used for office management, billing, or scheduling. However, these additional services can be purchased at fair market value. A group practice can make a similar donation to physicians who are members of the group practice or a prescription drug plan. Also, a Medicare Advantage organization can make a donation to a prescribing physician. Any time free goods are exchanged—regardless of the benefit to the patient—the donation can be construed as remuneration to the physician. As a result, the limitations are fairly well spelled out on what can and cannot be given, and to whom. Timmons offered these guidelines: • Under the ePrescribing Safe Harbor, the donation must be used to access an e-prescription drug program that meets applicable Part D standards. • Neither the donor nor the donor’s agent can use the exchange to limit or restrict interoperability. A hospital, for example, cannot say it will accept or deny exchange of electronic health information as a condition of the donation. • The donor or donor’s agent cannot limit applicability based on payor status. • A physician or group practice may not make receipt of the items or services a condition of doing business with the donor, nor can it use the donation as an inducement to doing business. The reverse also applies: A physician or group practice may not say it will send patients solely to that particular hospital as a result of the donation. • Eligibility of physicians cannot be dependent on volume of services, prescriptions, as well as the amount of revenue the physician refers to the hospital. Be sure to document your decision to give or receive. An inventory of current software and hardware and how it is used can help both the donor and recipient understand what can be identified as “necessary.” The physician must provide certification that the donated items and services do not duplicate items and services already obtained. The certification must be full, complete, and accurate to the best of the recipient’s knowledge and certification must continue as donated upgrades occur. Likewise, the donor cannot dismiss the certification process under the guise of “I don’t care, and don’t want to know.” Soliciting
Public Opinion It’s anticipated that vendors, hospitals, and pharmacies will respond with comments. But physicians are urgently called on to also comment, especially since they will ultimately be evaluated by the walls built around the donations. There are 55 areas where the CMS and the OIG are soliciting advice. The following condensed questions give you an idea of some areas where you can influence the outcome: • How should the CMS approach practices that intentionally divest outdated items in exchange for receiving donated items? • How should the CMS measure whether the donated hardware is used for e-prescribing and EHR interoperability? • Should there be a cap on the amount of hardware and software that can be donated? Should the value be based on retail or nonretail costs? Given the wide range of EHR software costs, how would the cap apply if your practice was a better match to one vendor over another? Should the cap apply to both rural and urban settings? • Should contracted physicians be allowed to receive donated items and services? • How can e-prescribing software limit access to electronic health information and still promote quality of care and patient safety? • Should EHR software also contain a computerized physician order entry component? These exceptions and the safe harbor are expected to disappear when certification for interoperability standards is accepted. Some predict that may be in the middle to end of 2006—others suggest it may be in 2007. What
Do These Regulations Mean to the Physician Practice? Will your practice blend with ONCHIT’s envisioned model of “Consumer-centric and Information-rich Health Care?” • Medical information follows consumers so they are at the center of their care. • Clinicians have appropriate access to a patient’s clinical information and complete treatment history, can order medications with computerized systems, and can receive electronic reminders. • Quality initiatives result in robust performance competition. • Clinical research
and care delivery can be linked. — Carolyn P. Hartley is president and CEO of Physicians EHR, LLC and moderates audio seminars that help physicians select, implement, and improve office efficiency through electronic health records.
2. 42 CFR Part 411,
Medicare Program: Physicians’ Referrals to Health Care Entities
With Which They Have Financial Relationships; Exceptions for Certain
Electronic Prescribing and Electronic Health Records Arrangements;
Proposed Rule, Agency: Centers for Medicare & Medicaid Services,
Health and Human Services.
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